(160 days)
The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).
The Benvenue VCF Osteo Coil System is packaged as a single-use, sterile, non-implantable device. It is a surgical instrument designed to be used in percutaneous applications, for the creation of channels within the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA). The Benvenue VCF Osteo Coil System consists of three primary components: Nitinol Osteo Coil, Deployment Cannula with PEEK liner, and Handle. The nitinol Osteo Coil is pre-set into a loop shape and can be temporarily straightened into a cannula for deployment into cancellous bone. Once positioned in the cancellous bone, the Osteo Coil is advanced forward out of the cannula. The surgeon controls the amount of Osteo Coil deployment with the use of the handle, which allows for incremental deployment and directional control. Upon exiting the Osteo coil regains its loop shape as it channels through the cancellous bone. The device is available in two sizes. This system does not include the bone cement.
The provided text describes a 510(k) submission for the Benvenue VCF Osteo Coil System, a surgical instrument. It details the device, its intended use, and claims of substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets them.
The "Discussion of Nonclinical Tests" section states: "The safety and performance of the Benvenue VCF Osteo Coil System have been substantiated through extensive non-clinical testing. Results of testing show that the Benvenue VCF Osteo Coil System can reliably and safely perform as intended in the treatment of pathological compression fractures of the vertebral body, by creating channels within the existing spinal bone structure in preparation for the flow of polymethylmethacrylate bone cement (PMMA). No new questions of safety or effectiveness have been raised."
This statement is a high-level summary and does not provide the specific details required to answer the request, such as a table of acceptance criteria, reported performance, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.
Therefore, I cannot provide the requested information from the given text. The text confirms that non-clinical tests were performed to substantiate safety and performance, but it does not describe these tests or their results in sufficient detail to fulfill your requirements.
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Image /page/0/Picture/0 description: The image shows a sequence of characters, seemingly handwritten, that reads 'K070293'. The characters are bold and slightly irregular, suggesting they were written quickly or with a thick marker. The 'K' is distinct, followed by a zero, then '70293', all in a single line.
5. 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92
Submitter: BENVENUE MEDICAL, INC 1235 Pear Ave., Suite 111 Mountain View, CA 94043 Phone: 650 934 - 0400 Fax: (650) 967-4035
JUL 1 0 2007
Contact: Laurent Schaller, President 1235 Pear Ave., Suite 111 Mountain View, CA 94043 Phone: (650) 934-0400
Date Summary was Prepared: July 9, 2007
| Device Proprietary Name: | Benvenue VCF Osteo Coil System |
|---|---|
| Regulation Number: | 888.4540 |
| Classification Name: | Orthopedic Manual Surgical Instrument |
| Device Product Code: | OCJ |
Predicate Device(s): The Benvenue VCF Osteo Coil System is substantially equivalent to the following devices:
| Device & Manufacturer | Manufacturer | 510(k) No.or status |
|---|---|---|
| ARCUATETM Vertebral Augmentation System(ARCTM Osteotome instrument) | Medtronic SofamorDanek | K063248 |
| Radial Disc CutterAccessory within the Trans-sacral Spinal Access & PreparationDevice | Trans1, Inc | K032891 |
| Spineology Bone Reamer | Spineology, Inc. | Class IExempt |
| KINSA Suture Anchor | Smith & Nephew, Inc | K061154 |
Device Description:
The Benvenue VCF Osteo Coil System is packaged as a single-use, sterile, non-implantable device. It is a surgical instrument designed to be used in percutaneous applications, for the creation of channels within the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA). The Benvenue VCF Osteo Coil System consists of three primary components: Nitinol Osteo Coil, Deployment Cannula with PEEK liner, and Handle. The nitinol Osteo Coil is pre-set into a loop shape and can be temporarily straightened into a cannula for deployment into cancellous bone. Once positioned in the cancellous bone, the Osteo Coil is advanced forward out of the cannula. The surgeon controls the amount of Osteo Coil deployment with the use of the handle, which allows for incremental deployment and directional control. Upon exiting the Osteo coil regains it
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loop shape as it channels through the cancellous bone. The device is available in two sizes. This system does not include the bone cement.
Statement of Intended Use:
The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).
Discussion of Nonclinical Tests:
The safety and performance of the Benvenue VCF Osteo Coil System have been substantiated through extensive non-clinical testing. Results of testing show that the Benvenue VCF Osteo Coil System can reliably and safely perform as intended in the treatment of pathological compression fractures of the vertebral body, by creating channels within the existing spinal bone structure in preparation for the flow of polymethylmethacrylate bone cement (PMMA). No new questions of safety or effectiveness have been raised
Substantial Equivalence:
The Benvenue VCF Osteo Coil System product information, technological comparison to predicate products, and test results demonstrate that the Benvenue VCF Osteo Coil System is safe and performs as intended. The Benvenue VCF Osteo Coil System is substantially equivalent to the currently marketed predicate devices with respect to intended use, materials and technological characteristics.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BENVENUE MEDICAL, INC. % Mr. Laurent Schaller President 1235 Pear Ave., Suite 111 Mt. View. California 94043
JUL 1 0 2007
Re: K070293
Trade/Device Name: Benvenue VCF Osteo Coil System Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic manual surgical instrument Regulatory Class: Class I Product Code: OCJ Dated: May 31, 2007 Received: June 5, 2007
Dear Mr. Schaller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 888.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type, that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 888.9 will be exempt from the premarket notification requirements of the Act.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Laurent Schaller
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address:
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours
Barbara Buehup
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K070293
Device Name: Benvenue VCF Osteo Coil System
Indications for Use:
The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Valerie Buell
Division of General, Restorative, and Neurological Devices
510(k) Number_KOJO293
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§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.